Mobilizing Early Management of Mental Health Complications After Mild Traumatic Brain Injury
- Conditions
- Mild Traumatic Brain Injury
- Interventions
- Other: Generic information about concussion managementOther: Guideline implementation tool
- Registration Number
- NCT04704037
- Lead Sponsor
- University of British Columbia
- Brief Summary
Mental health problems frequently complicate recovery from mild traumatic brain injury (mTBI) but are under-recognized and under-treated. Our research program aims to identify evidence-based strategies for closing this knowledge-practice gap. Building on a successful pilot trial, the reseachers will evaluate the effectiveness of a clinical practice guideline implementation tool designed to support proactive management of mental health complications after mTBI in primary care.
- Detailed Description
Goal: To determine if a clinical practice guideline implementation tool, designed to support proactive management of mental health complications, can improve clinical outcomes from mild traumatic brain injury (mTBI).
Background: Up to 1 in 4 people who sustain an mTBI develop depression or an anxiety disorder within the first 3 months. Mental health problems triple the risk of long-term disability after mTBI. However, mental health disorders after mTBI are under-detected and under-treated. Canadian clinical practice guidelines for mTBI developed by the Ontario Neurotrauma Foundation (ONF) recommend that family physicians proactively screen and initiate treatment for mental health disorders.
Aims: To evaluate the effectiveness of an implementation intervention designed to facilitate timely detection and treatment of mental health complications in primary care.
Approach: Triple-blinded (treatment provider, patient, assessor) cluster randomized controlled trial with two arms. The intervention involves collecting screening test results from patients and a complex intervention with two components: sharing the screening test results in an actionable format with their family physician and activating patients for the clinical encounter with the family physician by sharing education materials about mental health problems and treatment options after mTBI. The comparison group is usual care.
Hypotheses: The researchers hypothesize that the guideline implementation tool will be associated with lower rates of mental health complications at 26 weeks post-injury, compared to usual care.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 537
- Age 18-69 years old,
- presentation to emergency department within 72 hours of injury,
- probable mTBI diagnosis per emergency department chart review and interview based on World Health Organization Neurotrauma Task Force diagnostic criteria,
- fluent in English,
- primary residence in British Columbia,
- designate a specific family physician or walk-in clinic where they plan to seek follow-up care
- Pre-existing unstable/serious medical condition (e.g., cancer, multiple sclerosis, etc.)
- Pre-existing unstable/severe mental illness (e.g., schizophrenia requiring hospital admission in past year)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Minimally enhanced usual care Generic information about concussion management See intervention/treatment description Arm 2: Guideline implementation tool Guideline implementation tool See intervention/treatment description
- Primary Outcome Measures
Name Time Method MINI version 7.0.2 for DSM-5 26 weeks post injury Structured diagnostic interview
- Secondary Outcome Measures
Name Time Method World Health Organization Disability Assessment Schedule 2.0 12-item version 12 and 26 week post injury Standardized interview
Rivermead Postconcussion Symptom Questionnaire 2, 12, 26 weeks post injury Standardized questionnaire
Trial Locations
- Locations (9)
Urgent and Primary Care Center: North Vancouver
🇨🇦North Vancouver, British Columbia, Canada
University Hospital of Northern British Columbia
🇨🇦Prince George, British Columbia, Canada
Lion's Gate Hosital
🇨🇦North Vancouver, British Columbia, Canada
Richmond Hospital
🇨🇦Richmond, British Columbia, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Mount Saint Joseph's Hospital
🇨🇦Vancouver, British Columbia, Canada
University of British Columbia Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Urgent and Primary Care Center: City Center
🇨🇦Vancouver, British Columbia, Canada